The role of Good Documentation Practices on Compliance Activities

The role of Good Documentation Practices on Compliance Activities. An acceptable definition of Good Documentation Practices (GDP) would be the prescribed standards by which documentation is created and maintained in the pharmaceutical industry. The FDA has set some GDP standards, but these are not the only GDP standards. There are others that come under the […]

Most Common Problems of Software Validation Processes

Most Common Problems of Software Validation Processes. Software validation processes have always been important; yet, they acquired a special sense of urgency and added importance following the announcement in August 2010 by the FDA in this regard, in which it stated that it “…will be conducting a series of inspections in an effort to evaluate […]

Supplier and Internal Auditing

Supplier and Internal Auditing. The criticality of auditing to the field of medical devices can never be understated, because medical devices play a direct role in human safety. Supplier and internal auditing are separate, but related aspects of the supply chain and quality aspects of medical devices. It is a common practice in the industry […]

Verification and Validation of HACCP

Verification and Validation of HACCP. Hazard Analysis Critical Control Point (HACCP) is a mechanism meant for ensuring food safety. It is a comprehensive set of guidelines that straddles across the food supply chain, right from harvest till the time it is consumed.Being such a systematic and total approach; HACCP attaches utmost importance to prevention of […]

The impact of effective complaint handling on quality system

Effective complaint handling makes an extremely important impact on the quality system. An effective complaint handling is at the core of a quality system. If a product enters the market having got FDA approval and still receives complaints, it means that the device needs to be worked on and the complaint redressed. Effective complaint handling […]

Technical file vs design dossier

One of the important points that a medical device professional encounters is this: the technical file vs design dossier. The reason for the confusion about these two is that there are different names of the same concept and vary according to the class of device and the Notified Body that approves it. This is what […]

Supplier quality audit training

Most medical device companies have auditors that assess the quality of the product from the supplier. This is the supplier quality audit. Supplier quality audit training is the training that is needed to be qualified to assess the quality of a product from the supplier. Auditors, regardless of whether they are from inside the organization […]

Pharmacovigilance signaling

Pharmacovigilance signaling is an important aspect of pharmacovigilance. In simple terms, it is the detection of a new safety finding within a set of safety data which requires further investigation. The World Health Organization (WHO) defines pharmacovigilance signaling thus: ““reported information on a possible causal association between an adverse event and a drug, the relationship […]

Online compliance training

Compliance training is a vast area of continuing professional education. Professionals in any industry that requires compliance with set standards –this could mean almost any industry or profession –require compliance trainings. Compliance training is required in all these areas, and professional organizations offer these with the help of experts in the field. Online compliance training […]